Overweight
Conditions
Interventions
Drug Treatment Group:Subcutaneous injection for the treatment of GLP-1RA
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Age range: 18–55 years old (including the boundary values, based on the date of signing the informed consent form); 2.No limitations for both Gender; 3.Body Mass Index (BMI) >=24 kg/m^2, =28 kg/m^2; (Comorbidities include those of the endocrine and metabolic system such as type 2 diabetes, dyslipidemia, hyperuricemia; respiratory system conditions like obstructive sleep apnea syndrome; cardiovascular diseases such as coronary atherosclerotic heart disease and hypertension; urinary system issues like chronic kidney disease and stress urinary incontinence; reproductive system disorders like polycystic ovary syndrome; digestive system problems such as gastroesophageal reflux disease and metabolic dysfunction-related fatty liver; musculoskeletal conditions like osteoarthritis; and mental health disorders like depression and anxiety.); 4.Those who have no plans to conceive from the time of informed consent until the study follow-up period, and who voluntarily use effective contraceptive measures and have no plans to donate sperm; 5.The patient fully understands the purpose, nature, methods of the trial, as well as potential adverse reactions. The patient voluntarily participates in this study and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1.History of using weight loss medications within the past 3 months; 2.Those who have used GLP-1 receptor agonists/analogues or Dipeptidyl Peptidase IV inhibitors within the past 3 months; 3.History of weight loss surgery; 4.Severe hypertension, with systolic blood pressure (SBP) >=180 mmHg and/or diastolic blood pressure (DBP) >=120 mmHg; 5.Patients with a history of acute or chronic pancreatitis, symptomatic gallbladder disease (such as multiple gallstones), or a history of pancreatic injury, among other risk factors that may lead to pancreatitis; 6.History of medullary thyroid cancer, multiple endocrine neoplasia (MEN) 2A or 2B syndrome, or relevant family history; 7.Known to be allergic to the active ingredients (GLP-1 and GLP-1RA) of the research drug; 8.Any other circumstances that researchers believe may affect the patient’s ability to provide informed consent or comply with the trial protocol, or situations in which the patient’s participation in the trial could affect the trial results or their own safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of gonadal function indexes from baseline: luteinizing hormone (LH), follicle stimulating hormone (FSH), estradiol, progesterone, prolactin, total testosterone, free testosterone and SHBG.;Changes of fasting body weight relative to baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Body Mass Index (BMI) from baseline;Changes in waist circumference, hip circumference, and waist-to-hip ratio from baseline; | — |
Countries
China
Contacts
Public ContactQing Miao
Huashan Hospital, Fudan University
Outcome results
None listed